search
Back to results

Prevention Among Young People With Intellectual Disability

Primary Purpose

Intellectual Disability, Adolescent Development, Young Adult

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
"Children - what does it involve?"
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intellectual Disability focused on measuring Intellectual disability, Parenthood, Reproduction, Intervention, Adolescents

Eligibility Criteria

16 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Students with mild or moderate ID with informed consent can be included
  • Understand and respond to a questionnaire

Exclusion Criteria:

- Students with severe ID

Sites / Locations

  • Uppsala Special school

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Educational lessons based on the conversational material Toolkit "Children - what does it involve?", will be delivered in the classroom at school and caring for the RCB simulator during three days and nights.

Education as usual.

Outcomes

Primary Outcome Measures

Infant Simulator Attitude Scale (ISA)
The original ISA consists of 38 items of which most are statements with four response alternatives ranging from strongly agree to strongly disagree. It was translated to Swedish and to the cognitive level of students with intellectual disability. Statements were changed into questions and one response alternative "I do not know" was added. The items related to sexual activity and to contraception were omitted since it was not the focus of the intervention and also to ease the all over burden of lengthy questionnaires for the students.

Secondary Outcome Measures

General Self-Efficacy Scale (S-GSE)
The S-GSE contains 10 items and it has already been used in Sweden. The investigators adapted two of the items and added the response alternative "I do not know". The layout of the response alternatives was adapted to individuals with cognitive disability and the students were given the opportunity to use pictures or sign language for ease of understanding.
Data extracted from Real Care Baby simulator
Proper care, mishandle and performance - mean and range in percent

Full Information

First Posted
November 10, 2017
Last Updated
May 3, 2018
Sponsor
Uppsala University
Collaborators
Uppsala-Örebro Regional Research Council
search

1. Study Identification

Unique Protocol Identification Number
NCT03348124
Brief Title
Prevention Among Young People With Intellectual Disability
Official Title
Prevention of Unwanted Pregnancy and a Path to Informed Choice Among Young People With Intellectual Disability- a RCT, Intervention With Conversational Support and Real-Care-Baby Simulator
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Uppsala-Örebro Regional Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to evaluate an intervention using the Toolkit "Children - what does it involve?" and the "Real-Care-Baby" (RCB) simulator among students with intellectual disability (ID), using a cluster randomized trial design with waiting-list control group.
Detailed Description
Background: There is limited knowledge about how young people with ID can be facilitated in their process of deciding about parenthood. A feasibility study showed that it is possible to evaluate an intervention using the chosen instruments among students with ID in order to provide them with further insights about parenthood. Methods: Randomization of eleven clusters/schools to intervention and eleven clusters to waiting-list control. Intervention includes thirteen educational lessons and a three-day and night caring-session with the RCB simulator. Intervention will be given 1-2 lessons/week during 8-14 weeks. Data will be collected with questionnaires and interviews before and after intervention. In control group: Before and after waiting-list time and after intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Adolescent Development, Young Adult
Keywords
Intellectual disability, Parenthood, Reproduction, Intervention, Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cluster randomized intervention study with waiting list control group.
Masking
Outcomes Assessor
Masking Description
The researchers are outcome assessors, independent from the intervention.
Allocation
Randomized
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Educational lessons based on the conversational material Toolkit "Children - what does it involve?", will be delivered in the classroom at school and caring for the RCB simulator during three days and nights.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Education as usual.
Intervention Type
Behavioral
Intervention Name(s)
"Children - what does it involve?"
Other Intervention Name(s)
education as usual
Intervention Description
Thirteen educational lessons based on the conversational material Toolkit will be delivered in the classroom at school, two lessons per theme. The themes consists of: 1) a card game: "What i wish" 2) Time 3) Money 4) Skills 5) Relations 6) Housing. The material is prepared and same for all schools. This intervention will be given 1-2 lessons per week over a period of 8-14 weeks. During this period the students also care for the RCB simulator during three days and nights, but with a break for "day care" for the simulator which was between 7 am and 5 pm when the students were in school. All students will practice handling the simulator to be familiar with all types of needs: to rock, change diaper, feed and burp and were taught the skills of head support, techniques to avoid rough handling.
Primary Outcome Measure Information:
Title
Infant Simulator Attitude Scale (ISA)
Description
The original ISA consists of 38 items of which most are statements with four response alternatives ranging from strongly agree to strongly disagree. It was translated to Swedish and to the cognitive level of students with intellectual disability. Statements were changed into questions and one response alternative "I do not know" was added. The items related to sexual activity and to contraception were omitted since it was not the focus of the intervention and also to ease the all over burden of lengthy questionnaires for the students.
Time Frame
Change from baseline after 13 weeks
Secondary Outcome Measure Information:
Title
General Self-Efficacy Scale (S-GSE)
Description
The S-GSE contains 10 items and it has already been used in Sweden. The investigators adapted two of the items and added the response alternative "I do not know". The layout of the response alternatives was adapted to individuals with cognitive disability and the students were given the opportunity to use pictures or sign language for ease of understanding.
Time Frame
Change from baseline after 13 weeks
Title
Data extracted from Real Care Baby simulator
Description
Proper care, mishandle and performance - mean and range in percent
Time Frame
Change from baseline after three days and nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Students with mild or moderate ID with informed consent can be included Understand and respond to a questionnaire Exclusion Criteria: - Students with severe ID
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Höglund, PhD
Organizational Affiliation
Uppsala University Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala Special school
City
Uppsala
ZIP/Postal Code
74010
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevention Among Young People With Intellectual Disability

We'll reach out to this number within 24 hrs